Translation of Robotic Apparel for Alleviating Low Back Pain

Completed · Not applicable

Conditions studied: Low Back Pain

In brief

This is a NIAMS-sponsored clinical trial being conducted through the NIH Helping to End Addition Long-term (HEAL) Initiative's Back Pain Consortium (BACPAC) Research Program. This is a single-arm controlled trial with individuals aged 18-70 with low back pain (LBP). This study investigates the effect(s) of augmenting physical therapy (PT) interventions with the use of an experimental wearable soft robotic device ('exosuit').

Key facts

Study ID

NCT05736393

Run by

Boston University Charles River Campus

People needed

44

Starts

2024-03-15

Expected to finish

2025-05-10

Last updated by the study team

2025-12-08

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18-70
• Diagnosis of LBP by licensed medical provider or self-report of lower back pain (initially gathered through partial HIPAA waiver, and confirmed during in-person screening visit)
• Self-reported LBP with bending or lifting
• Able to walk without an assistive device.
• Willing and able to provide informed consent.
• Provide HIPAA Authorization to allow communication with the primary healthcare provider (e.g., treating physical therapist) for communication (as needed) during the study period.
• Must undergo physical therapy examination with research physical therapist and be assigned a Treatment-Based Classification (TBC) of movement impairment or control impairment.

You may not qualify if…

• Unable to attend all scheduled visits and 1-month phone follow-up
• Currently pregnant or likely to become pregnant within 6 weeks
• Having received surgery to address current LBP
• Having pain or symptoms below the knee that seems related to their current LBP
• Having current LBP lasting less than 2 weeks
• Diagnosed or self-reported neurological disorders effecting motor control (stroke, Parkinson's disease, etc.)
• Use of a pacemaker or other implanted medical devices
• Currently under treatment for cancer
• Skin issues / sensitivity that an exosuit could exacerbate (e.g., Epidermolysis Bullosa)
• Any other medical conditions that would preclude safe use of the exosuit device as determined by a physical therapist

Where it is running

• Boston University Physical Therapy Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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